BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2082198 · Received May 9, 2011

    Report

    Report Number
    2531779-2011-03237
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    April 12, 2011
    Report Date
    April 12, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILLED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT THE PUMP POWERS ON NORMALLY WITH NO ALARMS. DURING INVESTIGATION, THE BATTERY CAP ATTACHED SECURELY TO THE PUMP. THERE WAS NO DAMAGE NOTED TO THE BATTERY CAP OR THE BATTERY COMPARTMENT; NO DEFECTS WERE FOUND TO THE BATTERY CONNECTIONS OR TO THE POWER CIRCUIT. A REVIEW OF THE PUMP HISTORY INDICATED THAT REBOOTING HAD OCCURRED WHICH COULD NOT BE DUPLICATED DURING TESTING. THERE WERE NO ALARMS RELATED TO THE COMPLAINT NOTED IN THE ALARM HISTORY. THE PUMP WAS FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY. A REVIEW OF THE PUMP HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO INSULIN DELIVERY ISSUES.

    Description of Event or Problem · 1

    THE REPORTER ALLEGED THAT THE ANIMAS INSULIN PUMP HAS A SELF-REBOOT ISSUE. REPORTEDLY, THE PUMP IS REPEATEDLY SHOWING THE VERIFICATION SCREEN. AT THE TIME OF CONCERN, THE PATIENT'S BLOOD GLUCOSE WAS "363 MG/DL" WITH NO SYMPTOMS. THERE WAS NO REPORT OF MEDICAL INTERVENTION THAT WOULD SUGGEST A SERIOUS INJURY. DURING TROUBLESHOOTING, THE REPORTER NOTED THE FOLLOWING: SPRING/METAL CONTACTS AND THREADS ARE INTACT. THREADS IN BATTERY COMPARTMENT ARE INTACT. NO CRACKS FOUND NEAR BATT COMPARTMENT. CHIP IN PAINT LOCATED ON SEAM ON BOTTOM OF PUMP. BATTERY COMPARTMENT HAS NO EVIDENCE OF MOISTURE/CORROSION. THIS COMPLAINT IS BEING REPORTEDLY AS A MALFUNCTION DUE TO THE ALLEGED SELF-REBOOT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM IR1200/1250/2020/OTP CART

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR